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510(k) Data Aggregation
K Number
K980565Device Name
LD2000 SERIES
Manufacturer
Date Cleared
1998-03-19
(34 days)
Product Code
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
GENERAL SCANNING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications.
Device Description
The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications.
The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. The digitized information may then be transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems).
The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
The digitizer is a system for converting images on x-ray and films into digital data. It accomplishes this by scanning a focused laser beam across the film as the film itself is moved by means of motor-operated rollers. Solid state photo diodes are used to detect the amount of laser light which passes through the film at each pixel. This provides a measure of optical density at each pixel, and this measurement becomes the digital value for that pixel. The aggregate of the digital values for all the pixels on the film being digitized is thus a digital representation of the film's image. The digitizer sends this digital version of the image via an electronic interface.
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K Number
K973411Device Name
DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
Manufacturer
Date Cleared
1997-12-04
(86 days)
Product Code
Regulation Number
892.2030Why did this record match?
Applicant Name (Manufacturer) :
GENERAL SCANNING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.
Device Description
The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.
The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. A laser imager may then be used to print a copy of the original image.
The LD2800 contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
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